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Study of Pembrolizumab (MK-3475) or Placebo Given With Best Supportive Care in Asian Participants With Previously Treated Advanced Hepatocellular Carcinoma (MK-3475-394/KEYNOTE-394)

NCT03062358 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 453

Last updated 2025-09-30

Study results available
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Summary

The purpose of this study is to determine the efficacy and safety of pembrolizumab or placebo given with best supportive care (BSC) in Asian participants with previously systemically treated advanced hepatocellular carcinoma (HCC). The primary hypothesis of this study is that overall survival is prolonged in participants who receive pembrolizumab compared to those who receive placebo.

Conditions

  • Carcinoma, Hepatocellular

Interventions

BIOLOGICAL

pembrolizumab

Administered as an intravenous (IV) infusion every 3 weeks (Q3W)

DRUG

placebo

Normal saline solution administered as an IV infusion Q3W

OTHER

best supportive care (BSC)

BSC will include pain management and management of other potential complications including ascites per local standards of care.

Sponsors & Collaborators

Principal Investigators

  • Medical Director · Merck Sharp & Dohme LLC

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-04-27
Primary Completion
2021-06-30
Completion
2024-10-15

Countries

  • China
  • Hong Kong
  • Malaysia
  • South Korea
  • Taiwan

Study Locations

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Entities

Drugs
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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03062358 on ClinicalTrials.gov